Characterizing immune responses to zoonotic virus exposure in Cambodia

Characterization of Human Immune Signatures to Zoonotic Virus Exposure in Cambodia

This study is testing how healthy adults in Cambodia respond to viruses from animals to better understand their immune reactions.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) (NIH)
• Drugs / interventions: chemotherapy, immunotherapy, prednisone
• Locations: 5 sites (Battambang and 4 other locations)
• Trial ID: NCT06680843 on ClinicalTrials.gov

What this trial studies

This observational study aims to characterize the immune response to zoonotic virus exposure in healthy adults aged 18 to 65 years in Cambodia. Participants will be individuals with high-risk exposure to animals or their excreta, such as those involved in guano farming or living near animal habitats. The study will involve the collection of whole blood samples to analyze immune signatures related to viruses like H5N1. The research is conducted by the International Center of Excellence in Research Cambodia with support from NIH investigators.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 65 years who have had direct exposure to suspected infected animals or live within 5 km of animal habitats.

Not a fit: Patients who are pregnant or have chronic medical conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance understanding of immune responses to zoonotic viruses, potentially leading to better prevention and treatment strategies.

How similar studies have performed: While this approach is focused on a specific geographic and viral context, similar studies have shown promise in characterizing immune responses to zoonotic infections.

Eligibility criteria

Inclusion Criteria:

1. Capacity to provide informed consent.
2. Adult aged 18-65 years.
3. Have interaction with suspected infected animals within the last 2 years, including (but not limited to) the following risk factors:

   1. Hunting, slaughtering, or consuming suspected infected animals;
   2. Fruit collection, date palm sap harvesting, or tree pruning within agricultural plantations containing bat roosts;
   3. Bat guano farming;
   4. Ancillary work in live animal markets or wild animal habitats identified as likely containing infected animals (e.g., provision of cleaning, transportation, or tourism services);
   5. Living within 5 km of identified animal markets or wild animal habitats identified as likely containing infected animals.
4. Willing to allow biological samples and data to be stored for future research.

Exclusion Criteria:

1. Pregnancy (based on self-reporting).
2. Any underlying, chronic, or current medical condition that, in the opinion of the investigator, would interfere with participation in the study (e.g., inability or great difficulty in drawing blood, known anemia).
3. Self-reported symptoms suggestive of acute infection (acute myalgias, arthralgias, headache, retro-orbital pain, dyspnea, rash) within 7 days prior to enrollment.
4. Signs suggestive of acute infection (fever, defined as internal temperature \>38°C; hypoxemia, defined as peripheral oxygen saturation of \<90%; hypotension, defined as systolic blood pressure \<90 mm Hg or diastolic blood pressure \<50 mm Hg) present at screening.
5. Self-reported diagnosis of immune deficiency, including HIV infection, chronic corticosteroid use (≥10 mg prednisone dose or its equivalent for a continuous period of ≥30 days within the last 1 year), ongoing or prior (within the last 10 years) receipt of chemotherapy or immunotherapy, or current hematological malignancy.
6. Receipt of blood products, including immunoglobulin products, within 120 days of study enrollment.

Where this trial is running

Battambang and 4 other locations

• Communicable Disease Control Department — Battambang, Cambodia (Recruiting)
• Communicable Disease Control Department — Kampong Thom, Cambodia (Recruiting)
• Communicable Disease Control Department — Kampot, Cambodia (Recruiting)
• Communicable Disease Control Department — Stung Treng, Cambodia (Recruiting)
• Communicable Disease Control Department — Takeo, Cambodia (Recruiting)

Study contacts

• Principal investigator: Christina Yek, MD — NIH/NIAID/Laboratory of Malaria and Vector Research (LMVR)
• Study coordinator: Chanthap Lon, MD

Conditions Immunity, Humoral